Testing insulin therapy and insulin/ metformin combination therapy for Type 2 Diabetes Mellitus preventio

• Conditions: Type 2 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12611001216909
• Lead Sponsor: Rishaal Sharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

21 years of age or older

Not specific to any gender or ethnic groups;

Persons with HbA1c between >= 5.7% and <6.5%;

Persons with impaired glucose tolerance or impaired fasting glucose levels

Exclusion Criteria

Known diabetes (Fasting Plasma Glucose > 7.0 mmol/l; 2-hour 75-g OGTT plasma glucose > 11.1 mmol/l;

HbA1c result HbA1c<5.7% or > =6.5%;

Diabetes diagnosed by a physician and confirmed by other clinical data;

Self-reported hospitalization for treatment of heart disease in past 6 months;

Impaired renal and liver function, and pancreatitis;

Self-reported recent or significant abdominal surgery;

Self-reported pregnancy and/or intentional pregnancy during the study;

Self-reported hospitalization for stroke or transient ischemic attack episode in the past 6 months;

Anemia;

Inability to ensure availability for the next 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in fasting plasma glucose<br><br>test: plasma analysis to determine the baseline values of 2-hour 75-g OGTT plasma glucose[at baseline and at 3 months and 12 months after intervention commencement];change in glucose tolerance<br><br>test: plasma analysis using 2-hour 75-g OGTT plasma glucose[at baseline and at 3 months and 12 months after intervention commencement];change in HbA1c<br><br>test: blood sample analysis using HbA1c test kit[at baseline and at 3 months and 12 months after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
change in random blood<br><br>test: serum analysis using glucometer[at baseline and at 3 months and 12 months after intervention commencement];change in BMI[at baseline and at 3 months and 12 months after intervention commencement];number of participants that develop type 2 diabetes<br><br>test: fasting plasma glucose test and oral glucose tolerace test (OGTT) results will be compared against the diagnostic criteria of >7.0 mmol/L for fasting plasma glucose and >11.1mmol/L for OGTT[12 months after intervention commencement];number of participants that develops complications<br><br>test/ tools:<br>serum analysis using glucometer to check for hypoglycaemia.<br>questionnaires and medical reports to check and record other complications.[12 months after intervention commencement]